FDA requires warnings on two eczema drugs

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WASHINGTON – The labels on two prescription creams to treat eczema will have to bear “black box” warnings of possible cancer risks. The Food and Drug Administration action on Thursday follows an agency advisory committee recommendation last February that Elidel cream and Protopic ointment carry…
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WASHINGTON – The labels on two prescription creams to treat eczema will have to bear “black box” warnings of possible cancer risks.

The Food and Drug Administration action on Thursday follows an agency advisory committee recommendation last February that Elidel cream and Protopic ointment carry the label warnings. The new labeling also will clarify that the two drugs are recommended for use only after other prescription topical medicines have been tried by patients, the FDA said.

The “black-box” warning will be located lower down on the labels of the drugs than is typical.


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